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510(k) Data Aggregation

    K Number
    K121264
    Device Name
    TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
    Manufacturer
    MEDTRONIC SURGICAL TECHNOLOGIES
    Date Cleared
    2012-08-27

    (123 days)

    Product Code
    HBE, HBC, HRX, HWE
    Regulation Number
    882.4310
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC SURGICAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IPC System with the TRITON Electric High-Torque Handpiece is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
    Device Description
    The purpose of this submission is to add a new handpiece and an accompanying software module as a line extension to the current Integrated Power Console IPC® System. The handpiece is powered by the previously cleared integrated Powered Console. In order to operate the TRITON Electric Handpiece, the IPC will be equipped with the appropriate software module to drive the handpiece. The handpiece is used for sawing, drilling, driving and placing screws, wires and pins when used in conjunction with various attachments previously cleared for use during spinal surgery.
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